EMERCOIR: Nursing Homes Study of Fall Risk Assessment Oriented to Intervention

Sponsor

Fundacio Salut i Envelliment UAB (Other)

Overall Status

Completed

CT.gov ID

NCT00888953

Collaborator

Fondo de Investigacion Sanitaria (Other), Sociedad Española de Geriatría y Gerontología (Other)

331

Enrollment

Location

Arms

Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to establish the impact of a falls screening questionnaire in the adoption of preventive interventions and eventually in the reduction of falls and its consequences in elder people living in nursing homes.

Condition or Disease	Intervention/Treatment	Phase
Accidental Falls Activities of Daily Living Quality of Life Self-Efficacy	Other: Fall risk assessment Other: Tailored intervention	N/A

Detailed Description

Falls are the most frequent accidents in nursing homes, affecting more than a third of residents each year. Up to 10% of fallers require hospitalization or suffer a fracture. Psychological consequences affects between 20 and 80% of fallers, which suffer a lack of self-confidence that leads to reduction of activities and an increase of the dependence in activities of daily living.

Not all the residents have the same risk, and each person can have more than one risk factor that can be identified (previous falls, self confidence, weakness, gait disorders, dizziness, cognitive impairment, etc).

Identification of risk factors is the first step to reduce falls, but is not enough by itself. For this reason, interventions directed towards the correction of identified risk factors are required. In this setting, multifactorial interventions are the most successful to reduce falls numbers and its consequences.

As individual randomization of residents presents important inconveniences (group contamination, control arm residents could felt discriminated), we will randomized nursing homes to each group.

Study Design

Study Type:

Interventional

Actual Enrollment :

331 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Estudio de Medida Del Riesgo de Caídas Orientada a la Intervención en Residencias

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Residents living in nursing homes allocated to intervention group. Assessment of risk factors. Implementation of a multifactorial tailored program to prevent falls.	Other: Fall risk assessment Assessment of presence of risk factors (previous falls, self efficacy, balance and gait disorders, weakness, daily living impairment, limb pain, foot problems, dizziness, cognitive impairment, vision impairment, depression, urinary incontinence, heart disease, polimedication and consumption of neuroleptics and psychotropic medication) Other Names: Mini Falls Assessment (MFA) Other: Tailored intervention Induction of an intervention for each identified risk factor. If is possible the intervention will be directed towards the treatment of the underlying cause.
Other: Control Residents living in nursing homes allocated to control group. Assessment of risk factors. Receive the usual attention.	Other: Fall risk assessment Assessment of presence of risk factors (previous falls, self efficacy, balance and gait disorders, weakness, daily living impairment, limb pain, foot problems, dizziness, cognitive impairment, vision impairment, depression, urinary incontinence, heart disease, polimedication and consumption of neuroleptics and psychotropic medication) Other Names: Mini Falls Assessment (MFA)

Arm

Intervention/Treatment

Experimental: Intervention

Residents living in nursing homes allocated to intervention group. Assessment of risk factors. Implementation of a multifactorial tailored program to prevent falls.

Other: Fall risk assessment

Assessment of presence of risk factors (previous falls, self efficacy, balance and gait disorders, weakness, daily living impairment, limb pain, foot problems, dizziness, cognitive impairment, vision impairment, depression, urinary incontinence, heart disease, polimedication and consumption of neuroleptics and psychotropic medication)

Other Names:

Mini Falls Assessment (MFA)

Other: Tailored intervention

Induction of an intervention for each identified risk factor. If is possible the intervention will be directed towards the treatment of the underlying cause.

Other: Control

Residents living in nursing homes allocated to control group. Assessment of risk factors. Receive the usual attention.

Other: Fall risk assessment

Other Names:

Mini Falls Assessment (MFA)

Outcome Measures

Primary Outcome Measures

Number of fallers [one year]
People who at least have one fall during the follow-up period. Fall:unexpected event in which the participants come to rest on the ground, floor, or lower level

Secondary Outcome Measures

Number of falls [one year]
Number of falls per person/time.
Number of people who has a fracture as a consequence of a fall [one year]
Quality of life (only in residents without cognitive impairment). [One year]
Activities of daily living [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

People with or without cognitive impairment living indefinitely in a nursing home place
Able to walk with or without any kind of help or able to self transfer (as defined in category d420 of the WHO International Classification of Functioning, Disability and Health) without help
Give their consent (or the legal guardian in case of cognitive impairment).

Exclusion Criteria:

Terminal illness (expected death before 6 months).
Occupying temporarily a nursing home place (convalescence period) or another kind of place(day center, long term care, etc).